m-terphenyl-2'-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test material

Test material information

Constituent 1

Reference substance name:

m-terphenyl-2'-ol

EC Number:

219-401-9

EC Name:

m-terphenyl-2'-ol

Cas Number:

2432-11-3

Molecular formula:

C18H14O

IUPAC Name:

3-phenyl-[1,1'-biphenyl]-2-ol

Details on test material:

- Name of the test substance used in the study report: 2,6-Diphenylphenol
- CAS name: [1,1':3',1''-Terphenyl]-2'-ol
- Test substance No.: 10/0493-1
- Batch No.: LV 83/2010
- pH-value: ca. 4 (undiluted test substance, moistened with water and 20% aqueous preparation)
- Homogeneity: homogeneous by visual inspection
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor.

Test animals / tissue source

Species:

other: isolated bovine cornea

Details on test animals or tissues and environmental conditions:

TEST SYSTEM:
- Target tissue: isolated bovine cornea
- Source: Bovine eyes are obtained as a by-product of freshly slaughtered cattle (age of the animals: minimum 12 months, maximum 60 months).
- Supplier: Schlachthof Bensheim, Am Schlachthof 7-9, 64625 Bensheim

Test system

Vehicle:

water

Amount / concentration applied:

TEST-SUBSTANCE PREPARATION
- Test-substance preparation and homogenization until end of each application period: The test-substance preparation was produced on a weight per volume (w/v) basis shortly before application by stirring with a high speed homogenizer (Ultra-Turrax ) and a magnetic stirrer. The homogeneity of the test-substance preparation during application was provided by stirring with a magnetic stirrer.
- Vehicle: highly de-ionized water
- Reason for the vehicle: Highly de-ionized water has been demonstrated to have no adverse effects on the test system.
- Form of application: 20% (w/v) suspension in highly de-ionized water

APPLICATION:
- Topical application of 750 µL of a 20% test substance preparation to the epithelial surface of three isolated bovine corneas.

Duration of treatment / exposure:

4 hours

Number of animals or in vitro replicates:

3 isolated bovine corneas

Details on study design:

Negative control (NC): Highly de-ionized water
Positive control (PC): Imidazole (CAS No. 288-32-4) 20% (w/v) solution in highly deionized water for non-surfactant solid test substances

Each treatment group (test substance, NC and PC) consisted of 3 corneas. Before application the medium in the anterior chamber was removed. 750 μL of the 20% (w/v) test-substance preparation was applied directly to the epithelial surface of the cornea (open chamber method). Control tissues were concurrently applied into the anterior chamber with 750 μL of highly deionized water (negative control, NC) or with 750 μL of 20% (w/v) solution of Imidazole in highly de-ionized water (positive control, PC). The corneas were incubated in a horizontal position at about 32°C for approximately 4 hours. The NC and PC were then removed from the anterior chamber using a syringe and the epithelium was washed at least 3 times with Eagle’s MEM (containing phenol red) and once with Eagle’s MEM (without phenol red). Both chambers were then refilled with fresh Eagle’s MEM (without phenol red). Because the test substance could not be removed using a syringe, the epithelium was rinsed with the open chamber method.
Before measurement, each cornea was observed visually and observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer.

For determination of permeability the medium in the anterior chamber was replaced by 1 mL sodium fluorescein solution (5 mg/mL for solid test substances) and incubated for 90 ± 5 min in a horizontal position at about 32°C.
The amount of sodium fluorescein that permeated through the corneas into the posterior chamber was measured spectrophotometrically. Three aliquots per cornea were transferred to a 96-well microtiter plate and the optical density (OD490) was determined.

Results and discussion

Any other information on results incl. tables

Opacity score:

Test substance	Cornea No.	Initial opacity	Final opacity	Opacity change	Corrected opacity change	Mean	SD
10/0493-1	13 14 15	3.2 2.2 2.1	7.7 8.7 10.7	4.5 6.6 8.6	0.4 2.5 4.5	2.5	2.1
NC	1 2 3	0.8 1.3 1.9	2.8 2.7 10.9	2.0 1.3 8.9	NA NA NA	4.1	4.2
PC	4 5 6	4.6 2.5 4.7	64.1 66.6 82.9	59.6 64.2 78.2	55.5 60.1 74.1	63.2	9.7

Permeability score:

Test substance	Cornea No.	Mean OD490	Dilution factor	Mean corrected OD490	Mean	SD
10/0493-1	13 14 15	-0.007 0.006 0.027	1 1 1	-0.002 0.011 0.032	0.014	0.018
NC	1 2 3	-0.002 -0.006 -0.007	1 1 1	NA NA NA	-0.005	0.003
PC	4 5 6	0.606 0.770 0.701	5 5 5	3.035 3.853 3.510	3.466	0.411

In Vitro Irritancy Score (IVIS):

Test substance	Opacity per cornea	Permeability per cornea	IVIS
			per cornea	per group
				mean	SD
10/0493-1	0.4 2.5 4.5	-0.002 0.011 0.032	0.4 2.6 5.0	2.7	2.3
NC	2.0 1.3 8.9	-0.002 -0.006 -0.007	2.0 1.2 8.8	4.0	4.2
PC	55.5 60.1 74.1	3.035 3.853 3.510	101.0 117.9 126.8	115.2	13.1

NA = not applicable

Based on the observed results and applying the evaluation criteria it was concluded, that 2,6-Diphenylphenol does not cause serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.